Mammalian Process Development
Deep mammalian process development expertise is the foundation of our commitment to excellence.
Unlocking the Secret to Your Candidate’s Success
Through our teams’ vast proficiency in biologics development, we can devote our mastery in scientific innovation to fine-tune every aspect of your biologics manufacturing process. Our prowess extends to encompassing the major forms of product characterization, including in-depth analyses of stability and intricate explorations into mechanism of action studies. This equips us to better understand how your product design resonates with its subsequent manufacturing phases, so we can understand how any aspect of your product design might impact its later manufacturing, and how to account for that.
Our Strengths
Our team’s mammalian process development prowess lies in its ability to engineer and optimize highly efficient and scalable production processes for mammalian cell culture-derived biopharmaceuticals. Leveraging cutting-edge techniques and deep scientific insights, Tanvex empowers clients with tailored solutions that accelerate development timelines and ensure consistent, reliable, and cost-effective manufacturing.
- Highly technical staff with extensive development experience from IND to BLA submission
- Creative and collaborative cross-functional team enabling efficient parallel development activities and extensive product characterization
- Extensive use of DOE statistical software and high throughput technologies maximizing product knowledge while minimizing experimentation requirements
- Alignment of equipment with manufacturing and QC for ease of process and method transfer
Our Capabilities
Tanvex stands at the forefront of mammalian process development, excelling in the design, refinement, and scale-up of biopharmaceutical production processes. With a multidisciplinary approach and a focus on innovation, our team delivers customized solutions that drive efficiency, quality, and accelerated time-to-market for biologics offerings.
- Cell line development for mammalian systems
- High throughput media screening and optimization
- Mammalian cell culture development
- High throughput resin screening and chromatography development
- Filtration process development (depth, sterile, viral, TFF)
- Conjugation and pegylation process optimization
- Technology transfer and scale up
- Viral clearance study design and support
- Process characterization
